Chronic DiseasePhase 2NCT06401785
To Evaluate the Efficacy of Oral Molecular Hydrogen Supplement in Patients With Chronic Diseases
A Phase 2 study testing Hydrogen capsules in people with Chronic Disease and Chronic Inflammation, run by HoHo Biotech at 2 sites in Taiwan.
Trial summary
The supplementation of hydrogen molecules as an aid, adjuvant, may speed up recovering the course of the disease. The purpose of this study is to determine the possible efficacy and safety of solid hydrogen supplements for a clinical study in patients with chronic diseases. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Disease, Chronic Inflammation
- What is being tested?
- Hydrogen capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- 11 May 2024to 29 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 to 80
- Able to compliant with the protocol
- Able to return to the hospital regularly
- Patients with chronic inflammation, including patients with autoimmune diseases, metabolic-related diseases, chronic kidney disease or nephritis, tumor patients, etc.
Who cannot join
- Pregnancy
- Expected pregnancy
- Attending other clinical trials with 6 months
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Tri-Service General Hospital
Taipei
Min Chung Shen, M.D., +886 988521087, airfly100@gmail.com
Min Chung Shen, M.D.
- Recruiting
Taoyuan Armed Forces General Hospital
Taoyuan
Min Chung Shen, M.D., +886 988521087, airfly100@gmail.com
Min Chung Shen, M.D.
About this study
The supplementation of hydrogen molecules as an aid, adjuvant, may speed up recovering the course of the disease. The purpose of this study is to determine the possible efficacy and safety of solid hydrogen supplements for a clinical study in patients with chronic diseases. Patients will receive hydrogen capsules with their conventional treatment for 24 weeks. Investigators will test for any changes in haematologic, urine analysis and health status during and following the exposure period.
Read the detailed description
Hydrogen supplement has been shown to have significant removing effects on free radicals. International clinical trials have shown promise that hydrogen molecules may reduce chronic inflammatory and then speed up recovering the course of the disease.The purpose of this study is to determine the possible efficacy and safety of hydrogen supplements in different formula and dose exposures for a clinical study in patients with chronic diseases.Study design: 60 chronic diseases patients will be recruited from the Taoyuan Armed Forces General Hospital and Tri-Service General Hospital for this study. Participants will be screened by doctors for their eligibility and undergo a series of tests (questionnaires and examinations).Consenting participants will then be randomly allocated into 2 groups (experiment group and control group, single-blind study). In experiment group, participants will receive 2 solid hydrogen capsules every day for 24 weeks. In control group, participants will receive 2 capsules not containing hydrogen every day for 24 weeks. Participants will be examined their regular haematology, urine and health status before and after the intervention.
- Conditions
- Chronic Disease, Chronic Inflammation
- Being tested
- Hydrogen capsules
- Keywords
- Hydrogen supplement, Oral hydrogen capsules
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen capsulesDietary supplement
In experiment group, participants will receive 2 solid hydrogen capsules every day for 24 weeks. In control group, participants will receive 2 capsules not containing hydrogen every day for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Hydrogen capsules | Experimental | Hydrogen supplement Receives: Dietary Supplement: Hydrogen capsules |
| Placebo | Placebo comparator | Placebo supplement Receives: Dietary Supplement: Hydrogen capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Blood Routine
Change in Blood Routine, including WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, Lymphocyte, Monocyte, Eosinophil, Basophil, Neutrophil, Triglyceride, Cholesterol, HDL, LDL, ESR, and CRP
Measured: Change from Baseline of Blood Routine, and every return per 4 weeks during 24 weeks of the intervention
Improvement in Urine Routine
Change in Urine Routine, including GLU, PRO, BIL, URO, PH, SG, OB, KET, NIT, Uric acid, BUN, and eGFR
Measured: Change from Baseline of Urine Routine, and every return per 4 weeks during 24 weeks of the intervention
Improvement in the Health Assessment Questionnaire Disability Index (HAQ-DI) Questionnaire
Change in the (HAQ-DI) Questionnaire
Measured: Change from Baseline of HAQ-DI, and every return per 4 weeks during 24 weeks of the intervention
Improvement in the Disease Activity Score (DAS 28)
Change in the DAS 28
Measured: Change from Baseline of DAS 28, and every return per 4 weeks during 24 weeks of the intervention
Improvement in the Brief Fatigue Inventory-Taiwan (BFI-T)
Change in the BFI-T
Measured: Change from Baseline of BFI-T, and every return per 4 weeks during 24 weeks of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start11 May 2024 (estimated)
- Primary completion29 Dec 2024 (estimated)
- Study completion29 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In experiment group, participants will receive 2 solid hydrogen capsules every day for 24 weeks. In control group, participants will receive 2 capsules not containing hydrogen every day for 24 weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HoHo Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taoyuan Armed Forces General Hospital, Tri-Service General Hospital (TSGH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401785
- Sponsor's protocol ID
- C202305150
- Status last verified
- May 2024
- First submitted
- 18 Feb 2024
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy of Oral Molecular Hydrogen Supplement in Patients With Chronic Diseases
- ClinicalTrials.gov ID
- NCT06401785
- Acronym / sponsor ID
- C202305150
- Conditions
- Chronic Disease, Chronic Inflammation
- Keywords
- Hydrogen supplement, Oral hydrogen capsules
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- HoHo BiotechIndustry (pharma, biotech, devices)
- Collaborators
- Taoyuan Armed Forces General Hospital, Tri-Service General Hospital (TSGH)
- Study start
- 11 May 2024 (estimated)
- Primary completion
- 29 Dec 2024 (estimated)
- Study completion
- 29 Jan 2025 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The supplementation of hydrogen molecules as an aid, adjuvant, may speed up recovering the course of the disease. The purpose of this study is to determine the possible efficacy and safety of solid hydrogen supplements for a clinical study in patients with chronic diseases. Patients will receive hydrogen capsules with their conventional treatment for 24 weeks. Investigators will test for any changes in haematologic, urine analysis and health status during and following the exposure period.
Detailed description
Hydrogen supplement has been shown to have significant removing effects on free radicals. International clinical trials have shown promise that hydrogen molecules may reduce chronic inflammatory and then speed up recovering the course of the disease.The purpose of this study is to determine the possible efficacy and safety of hydrogen supplements in different formula and dose exposures for a clinical study in patients with chronic diseases.Study design: 60 chronic diseases patients will be recruited from the Taoyuan Armed Forces General Hospital and Tri-Service General Hospital for this study. Participants will be screened by doctors for their eligibility and undergo a series of tests (questionnaires and examinations).Consenting participants will then be randomly allocated into 2 groups (experiment group and control group, single-blind study). In experiment group, participants will receive 2 solid hydrogen capsules every day for 24 weeks. In control group, participants will receive 2 capsules not containing hydrogen every day for 24 weeks. Participants will be examined their regular haematology, urine and health status before and after the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In experiment group, participants will receive 2 solid hydrogen capsules every day for 24 weeks. In control group, participants will receive 2 capsules not containing hydrogen every day for 24 weeks.
| Arm | Type | Receives |
|---|---|---|
| Hydrogen capsules | Experimental | Dietary Supplement: Hydrogen capsulesHydrogen supplement |
| Placebo | Placebo comparator | Dietary Supplement: Hydrogen capsulesPlacebo supplement |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20 to 80
- Able to compliant with the protocol
- Able to return to the hospital regularly
- Patients with chronic inflammation, including patients with autoimmune diseases, metabolic-related diseases, chronic kidney disease or nephritis, tumor patients, etc.
Key exclusion criteria (3 listed)
- Pregnancy
- Expected pregnancy
- Attending other clinical trials with 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen capsulesIn experiment group, participants will receive 2 solid hydrogen capsules every day for 24 weeks. In control group, participants will receive 2 capsules not containing hydrogen every day for 24 weeks. | Dietary supplement | Hydrogen capsules, Placebo |
Primary outcome
Improvement in Blood Routine
Time frame: Change from Baseline of Blood Routine, and every return per 4 weeks during 24 weeks of the intervention
Change in Blood Routine, including WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, Lymphocyte, Monocyte, Eosinophil, Basophil, Neutrophil, Triglyceride, Cholesterol, HDL, LDL, ESR, and CRP
Improvement in Urine Routine
Time frame: Change from Baseline of Urine Routine, and every return per 4 weeks during 24 weeks of the intervention
Change in Urine Routine, including GLU, PRO, BIL, URO, PH, SG, OB, KET, NIT, Uric acid, BUN, and eGFR
Improvement in the Health Assessment Questionnaire Disability Index (HAQ-DI) Questionnaire
Time frame: Change from Baseline of HAQ-DI, and every return per 4 weeks during 24 weeks of the intervention
Change in the (HAQ-DI) Questionnaire
Improvement in the Disease Activity Score (DAS 28)
Time frame: Change from Baseline of DAS 28, and every return per 4 weeks during 24 weeks of the intervention
Change in the DAS 28
Improvement in the Brief Fatigue Inventory-Taiwan (BFI-T)
Time frame: Change from Baseline of BFI-T, and every return per 4 weeks during 24 weeks of the intervention
Change in the BFI-T
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Disease
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydrogen capsules in people with Chronic Disease and Chronic Inflammation, run by HoHo Biotech at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuang-Yih Wang, M.D. (+886 920757313, bbban1024@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Blood Routine (time frame: Change from Baseline of Blood Routine, and every return per 4 weeks during 24 weeks of the intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.